The United States Food and Drug Administration has approved for emergency use a single booster dose of Pfizer/BioNTech’s COVID-19 vaccine for children ages 5 to 11.
FDA said the booster dose should come at least five months after the completion of the primary vaccine series with the Pfizer-BioNTech COVID-19 Vaccine.
According to FDA Commissioner, Robert Califf, “While it has largely been the case that COVID-19 tends to be less severe in children than adults, the Omicron wave has seen more kids getting sick with the disease and being hospitalised, and children may also experience longer-term effects, even following initially mild disease.
Calif said Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe.
“If your child is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalisation and death,” he said.
The action expands the use of a single booster dose of the vaccine for administration to individuals 5 through 11 years of age at least five months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine.
The FDA has authorised the Pfizer-BioNTech COVID-19 Vaccine for use in individuals 5 years of age and older and has approved Comirnaty (COVID-19 Vaccine, mRNA) for use in individuals 16 years of age and older.
Director of FDA’ Centre for Biologics Evaluation and Research, Peter Marks added that the Pfizer-BioNTech COVID-19 Vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older.